The use of data in the research and development of new drugs has multiplied thanks to the advancement and contributions of personalized and precision medicine. This requires the management of patient information, both at a clinical, genetic and molecular level, to achieve greater effectiveness.
But the use of these data must be done with the maximum guarantees of safety for patients, who are owners and managers in the use of information considered sensitive. This was defended this Thursday by the coordinator of the Pharmaindustria Innovative Medicines Platform, Amelia Martín Uranga, at the forum The power of data and its relevance in the pharmaceutical sector, organized by Deloitte.
“The promotion of biomedical research – she said – has to respect the protection of patient data. Informed consent has always been spoken of as a formula to guarantee the adequate treatment of the data, but it is time to adapt the traditional paradigms to the new processes in accordance with other legal bases that the regulations on data protection allow and always guaranteeing the protection of the subjects in these investigations ”.
This reality is becoming more evident during the pandemic, especially in the most critical months, when research activity in hospitals came to a halt to respond to the emergencies caused by Covid-19. In Spain it could be quickly resumed, “thanks to the intervention of the Spanish Agency for Medicines and Health Products (Aemps) and also to the acceleration in the digitization of processes such as remote monitoring of clinical trials or work to advance in the digitization of informed consents ”, stressed Martín Uranga.
The truth is that biomedical research is in a moment of transition, in which clinical trials are “hybrids”, they combine face-to-face and virtual processes, which forces us to “take advantage of digital technology to allow all or some of the aspects of a clinical trial are carried out from the patient’s home or in a doctor’s office, instead of doing everything in the hospital, always taking into account the benefit for patients ”, he recalled.
In full digital transformation and when the European legislative proposal to harmonize the advances in the use of artificial intelligence was just known, Farmaindustria defends that health care and clinical research must go hand in hand in all areas, also in the field of health data. In this sense, the involvement of health administrations, the pharmaceutical industry and society is necessary to make it possible. “We are facing a very great opportunity that requires the collaboration of all,” defended Martín Uranga.
And more taking into account that clinical research is no longer just a matter of countries, but that the majority is pan-European or, in any case, of an international nature. For this reason, the spokesperson for Farmaindustria advocated a harmonization of the regulation of clinical data management in the European Union, eliminating legal fragmentation and adopting a comprehensive security infrastructure, “with cutting-edge technical and organizational security measures, to protect confidential data processed in the European health data space ”. It is also necessary to introduce data governance mechanisms that offer sufficient guarantees of lawful, responsible and ethical data management.
In this regard, she reported that Farmaindustria is working on a new Code of Conduct for the proper use of data in clinical research and pharmacovigilance, the design of which includes active responsibility on the part of pharmaceutical companies. “Undoubtedly, and as recognized by the European Data Protection Supervisor, this Code provides added value and contributes to the necessary harmonization for the management of health data,” said the representative of Farmaindustria.